BBI Solutions completes Acquisition of BioTeZ Berlin-Buch GmbH

BBI Solutions, the world’s leading independent provider of immuno-diagnostic reagents and contract services, has today announced the acquisition of “Biotez”.

BioTeZ Berlin-Buch GmbH (also including Steffens Biotechnische Analysen GmbH), is a Germany-based manufacturer of reagents and finished tests for the In-Vitro Diagnostics (“IVD”) market, as well as components for the food safety market.

The acquisition of BioTeZ & Steffens-Biotec adds capability and immediately enhances BBI’s portfolio and position as a ‘complete’ immunoassay reagent supplier – and therefore a natural partner for its customers.

The addition of BioTeZ unique Streptavidin based portfolio enhances BBI’s existing IVD Label portfolio with reagents such as Polystreptavidin, oligonucleotides and poly HRP. Furthermore the addition of immunoassay development services for ELISA or other formats complements BBI’s existing service offering and customers will benefit from an increased breadth of portfolio and expertise in bringing the next generation of diagnostic tests to market.

The UK-based business, which has manufacturing sites and sales offices across four continents, will integrate the “BioTeZ” & “Steffens-Biotec” manufacturing facilities in Germany, to offer customers unrivalled expertise across all aspects of the immunodiagnostic workflow.

BBI Solutions Chief Executive Officer, Mario Gualano said:

“This latest acquisition of BioTeZ and Steffens-Biotec further enhances our portfolio and positions BBI as a leading immunoassay reagent supplier.  It enables us to provide additional products and services in the fight against the COVID pandemic. The combined research and development capability will provide customers of both BioTeZ and BBI with new, innovative products and a broader portfolio for greater choice.

BBI Solutions is a progressive company with ambitious strategies in place. This development is a great achievement, particularly in these unfamiliar and testing times.”

The combined capability enables BBI to further service high growth disease segments such as cancer, diabetes, and non IVD sectors such as food safety while also enabling BBI to drive geographic expansion for BioTeZ and Steffens-Biotec, which will benefit from a bigger sales force.

Uwe Ahnert, CEO of BioTeZ GmbH, said:

“We are very proud to become part of the BBI family and to be able to reach many more customers worldwide.  In doing so, we will be able to support them in the production and development of innovative diagnostics.”

– ends –

Notes to Editors

  • BBI Solutions is a leading manufacturer of biological reagents and finished test platforms for the in-vitro diagnostics market. BBI is a global business with manufacturing sites and sales offices across four continents.
  • BBI’s range of raw materials includes human antigens, antibodies, serum and plasma products and clinical chemistry enzymes. BBI manufactures world renowned labels for lateral flow, ELISA assay and biosensors, including gold nanoparticles and glucose oxidase.
  • BBI Solutions offers lateral flow development and manufacturing services with a core focus on antibody development, gold conjugation, lateral flow test manufacture and mobile diagnostic solutions with Novarum™ technology.



Media Contact

Alastair Milburn (Effective Communication)

T: +44 (0)7813857328


Exponent announces sale of BBI Group to Novo Holdings

Exponent announces that it has reached an agreement to sell BBI Group (“BBI”), a leading supplier of products and services to the global diagnostics and life sciences industries, to Novo Holdings A/S, a leading global life sciences investor, for an enterprise value of over £400 million.

Founded in 1986, BBI provides critical reagents and immunoassay development, lateral flow development, diagnostic manufacturing services, and smartphone reader technologies to a global blue-chip customer base that includes Thermo-Fisher, Merck and Siemens. The company’s market-leading brand, BBI Solutions, provides a range of products, including antibodies, antigens, labels, complementary reagents and point of care tests. BBI is headquartered in South Wales and employs over 400 employees across its sites in seven countries and four continents.

Exponent acquired BBI as a corporate carve-out from US-listed Alere (now Abbott) in 2015. During its ownership, Exponent has transformed BBI into one of the world’s leading diagnostics platforms with a comprehensive suite of solutions for its growing and diversified client base.  Over the last five years, BBI has strengthened its management team, expanded its presence in the US, built operations in China, successfully completed three acquisitions (Novarum™ DX, Maine Biotechnology Services and Diarect) to expand the business’ product portfolio and invested in a state of the art manufacturing facility in Wales. These initiatives have delivered significant revenue growth and an EBITDA CAGR of 22% between 2017 and 2020.

James Gunton, Partner at Exponent, said: “We are delighted with the success of BBI under Exponent’s ownership. We have enjoyed working with Mario and the team over the last five years in transforming BBI into a world-class diagnostics platform for the healthcare and life sciences industry. We wish both the management team and Novo Holdings every success for the future and look forward to seeing the company continue to prosper.”

Mario Gualano, Group CEO of BBI Group, said: “We are hugely grateful to Exponent for the support we have received over the last five years. We have grown revenues and profitability considerably through investing in our products and services, people, and world-class infrastructure. We now have a fully invested and scalable platform to deliver future growth in a large and fast-growing market.

We are delighted to be working with Novo Holdings, a team with a strong track record and a shared vision for growth and innovation.”

Johan Hueffer, Senior Partner at Novo Holdings, said: “We are proud to be the next owners of BBI. Diagnostics is a very attractive space which, with an enhanced global focus on preventative medicine, will play an increasingly important part in improving health outcomes for patients around the world.  We see tremendous opportunities for both organic and inorganic growth for the company. Novo Holdings is looking forward to contributing its considerable industry expertise and extensive network in supporting the talented team at BBI.”

Alan Peterson OBE, Chairman of BBI Group, said: “I am delighted with the huge progress we have made at BBI in recent years and that under Novo Holdings, the company will continue to be headquartered from our new South Wales centre of excellence.”

For further information, please contact:

FTI Consulting (PR to Exponent and BBI Group)

Kit Dunford |+44 (0)7717 417 038 |

Katherine Bell | +44 (0)7976 870 961 |


About BBI Group

Established in 1986, BBI Group is a leading supplier of products and services to the global diagnostics and life sciences industries. The business has manufacturing sites spanning four continents and is headquartered in Crumlin, Wales. The Group’s brand, BBI Solutions, has served the global diagnostics industry for over 30 years, offering lateral flow development and manufacturing services with a core focus on antibody development, gold conjugation, lateral flow test manufacture and mobile diagnostic solutions with Novarum™ technology.

Novarum™️ app success for Conidia Bioscience amid pandemic disruption

BBI Solutions’ pioneering Novarum™️ technology has facilitated a 400% increase in usage of Conidia’s FUELSTAT test over the last 12 months.

Working with sectors including aviation, marine and offshore, backup power generation and transportation, microbial fuel testing company Conidia Bioscience has experienced a surge in demand for its on-site rapid testing technology.

BBI Solutions partnered with Conidia Bioscience, makers of the market leading FUELSTAT® test kits, in 2017 to develop a mobile app to verify results of tests detecting microbiological contamination in diesel or jet fuels. Since then, Conidia and BBI have been working closely together to review feedback from users in the field to shape future developments.

Requiring only a droplet of water in fuel to thrive, microbial growth has the potential to cause severe disruption. It is an issue that could cost the aviation industry millions in lost revenue every year and as many fleets have been grounded due to the pandemic, there is an increased risk of fuel tanks becoming contaminated.

The partnership between BBI Solutions and Conidia Bioscience provides a full test and mobile solution, helping prepare aircraft for service again, ensuring backup power is available to keep data centres running, and maintaining the quality of fuel systems across many critical industry applications.

Dr Mario Gualano, Chief Executive of BBI Group said:

“Our partnership with Conidia Bioscience using our Novarum technology in combination with their test kits demonstrates our commitment to address challenges faced in aviation industry, particularly during the pandemic”.

BBI Solutions’ patented Novarum™️ technology transforms a smartphone into an accurate test reader, empowering users to read, share and store their results as part of a connected mobile eco-system.

The application acts as a seamless extension to Conidia’s testing process; the end-to-end solution enabling technicians to take a sample on site, perform the test and share results digitally anywhere around the globe within 15 minutes.

Following the success of the feature over the last year, Conidia Bioscience has this month launched a new version of the application and online portal to provide all customers with a unique, full digital test solution.

Redesigned from the ground up for greater speed of response and reliability of result, the application contains many new features designed for ease of use by customers, whilst retaining familiarity for existing FUELSTAT® users.

Dr Neil Polwart, Head of Mobile at BBI Solutions, said:

“Microbial fuel contamination is a common and costly issue for the aviation industry and other sectors that rely on jet, or diesel fuel to power their operations.

“We developed this breakthrough product with Conidia, combining our innovative Novarum™️ reader technology with the firm’s comprehensive immunoassay to transform the way fuel contamination tests are performed. It is fantastic that affected sectors are being proactive and using FUELSTAT® tests, and we are pleased to continue to support the development of the application to further improve process efficiency and data capture.”

Leif Friestad, Managing Director of Conidia Bioscience, said:

“As industry harnesses the power of smartphones to drive advances in safety, security and compliance, BBI Solutions’ Novarum™️ technology has been a significant value-add for us and our customers.

“The ability to test and share results quickly saves time, money, disruption and, potentially, lives.”

Novarum holds patents in Europe, the US, China, Japan and Russia and BBI is also ISO 13485:2016 certified for Medical Device Quality Management Systems.

New BBI Solutions Novarum™️ feature to support Covid certificates

BBI Solutions today announced it has developed a new mobile feature to facilitate the creation and sharing of digital Covid test certificates, supporting employers, travel providers and the safe reopening of venues and events globally.The Crumlin-based manufacturer’s patented Novarum™️ technology transforms a smartphone into a diagnostics test reader, empowering users to read, share and store their results from the point of care.
The advanced technology will enable individuals to store a digital version of their Covid test on their own phone in a form that can be verified by anyone via a QR code.Based on the Apple and Google approach for boarding passes, users will not need to install any new apps thanks to the new feature being built using a trusted existing interface compatible with all smartphones. The QR code will be stored in the wallet feature of the smartphone, allowing the individual to control access to their personal results.BBI’s Novarum™️ technology is used to read diagnostic tests around the world, and a version of the product has just been certified with a CE (Conformité Européenne / European Conformity) mark, meaning it can be legally sold within the EU and is available for commercial distribution, to record the results of Sars-Cov-2 antibody tests and enabling independent verification of vaccination.The additional feature will play a supporting role in the loosening of restrictions and reopening of the economy, with employers, venues and organisations able to scan QR codes and check an individual’s test or vaccination status.Dr Mario Gualano, Chief Executive of BBI Group, said:“This is an exciting development which will prove beneficial to both individuals and businesses as the country gradually reopens after this latest lockdown. We are incredibly pleased to have achieved a CE mark for our innovative application; this will be a real confidence boost for global governments and private sector businesses looking to embrace the technology.”

Dr Neil Polwart, Head of Mobile at BBI Solutions, said:

“Using our expertise and experience in the development and delivery of next generation diagnostic technologies within mobile health, we have created this Novarum™️ feature to be simple, secure and shareable and with the readiness to deploy at scale within weeks. With its functionality for both antigen and antibody testing, the easy-to-use application will support test providers and users through the whole process.”

The new test certification capability developed by BBI Solutions complements its existing Novarum™️ offerings to the diagnostics industry, supporting the taking, reading and communication of test results.

BBI’s Novarum™️ pioneering technology can be used by anyone, anywhere, with minimal training, connecting patients and doctors, field workers, lab researchers and primary care clinicians to specialist practices as part of a mobile eco-system.

Used across a wide range of different assay formats and applications, including lateral flow and ELISA tests, the platform’s accuracy, connectivity and ease of use has been invaluable for the medical, veterinary, defence, agricultural and environmental sectors.

Novarum holds patents in Europe, the US, China, Japan and Russia and BBI is also ISO 13485:2016 certified for Medical Device Quality Management Systems.

BBI Solutions announces the launch of two new SARS-Cov-2 Antigens

BBI Solutions announces the launch of two new SARS-Cov-2 Antigens as critical raw materials for IVD manufacturers developing next generation serological COVID-19 diagnostic kits.

BBI’s recently-acquired and well-respected team based in Freiburg, Germany (DIARECT GmbH) has developed two new recombinant antigen preparations produced in Baculovirus transfected Sf9 cells.

The antigens Nucleocapsid (N) protein and Spike (S) glycoprotein Receptor Binding Domain (RBD) have been designed as critical raw materials for next generation serological assays.

With the continuing COVID-19 vaccination programme, testing for antibody response will become increasingly important. Antibody tests detecting immune response to both the conserved and abundant nucleocapsid and the receptor binding domain that is unique for the SARS-CoV-2 will deliver physicians important information for disease management.

Serology testing is strongly suggested to play a major role in screening populations to determine exposure, as well as potential immunity, to identify recovering individuals as plasma donors as well as for research on immune response and to help identify neutralising antibodies (Amanat et al. 2020; Farnsworth and Anderson 2020; Okba et al. 2020).

BBI Solutions has seven manufacturing sites across three continents and has an established reputation as a leading manufacturer of biological reagents and finished test platforms for the in-vitro diagnostics market. The Lateral flow manufacturing centre of excellence in Wales, UK is also part of the UK-Rapid Test Consortium (UK-RTC). BBI Solutions has recently acquired the Germany-based specialist manufacturer of autoimmune, infectious disease and allergy antigens DIARECT last year. This is the first of a pipeline of new products.

BBI’s two novel antigens are produced and characterised in the company’s ISO 13485:2016 compliant laboratories in Freiburg, Germany.

Dr Mario Gualano, Chief Executive of BBI Group, said: “These recombinant antigens are a welcome addition to our product catalogue and complement our existing range. We were delighted that our expertise in Freiburg can add a further component to the support BBI can offer the IVD industry in the fight against this Pandemic.”

You can view the dedicated SARS-Cov-2 Antigens webpage and request a sample today here

Iceni Diagnostics appoint BBI to produce their Covid-19/Influenza test

Iceni Diagnostics has appointed BBI Solutions to generate clinical trial batches for their new, rapid SARS-COV-2/Influenza virus detection test. The test exploits the diagnostic company’s unique, proprietary HPGR™ (Host-Pathogen Glycan Recognition)  technology to detect the presence of live virus in non-invasive samples within 15 minutes.

The agreement between Iceni Diagnostics and BBI will transfer protocols to standard lateral flow equipment. This work will enable the generation of devices for clinical trials, with the expectation of moving to assay scale-up and manufacturing transfer.

BBI is an ISO 13485 accredited manufacturer and will work with Iceni Diagnostics to deliver the necessary information required for CE marking of the final product. In parallel, similar studies will be undertaken in the US through a comparable program with a US manufacturer.

Professor Rob Field (pictured), CEO of Iceni Diagnostics said: “We are delighted to be working with BBI on our rapid SARS-COV-2/Influenza diagnostic. BBI has a clear understanding of our unique HPGR™ technology, and we are confident they can help us meet our ambitious targets to get product to market as quickly as possible.

“We are excited about the potential of this test.  Our proprietary technology identifies intact virus, unlike most existing tests that identify viral genetic material.  This crucial difference means that a positive result is a key indicator that live, active virus is present, giving a clear signal of current infection, whether the patient has started to show symptoms or not. Significantly, the test may also identify asymptomatic carriers and thus limit virus spread. It will similarly give rapid clearance to those who need to return home or to their school or workplace but who may still be carrying inactive virus particles following infection.

“We are manufacturing a duplex test that differentiates between SARS-COV-2 and Influenza from one sample.  Covid-19 and human flu have similar symptoms so our test will be vital in supporting lockdown decisions during the winter flu season.

“The test is housed in a lateral flow device, with results available within 15 minutes. This makes it ideal to use as a rapid triage option to complement laboratory testing.

“Much interest is being generated worldwide and Iceni Diagnostics is heavily involved in generating the required investment to rapidly accelerate validation, manufacture and distribution to the global market.”

Dr. Mario Gualano, Chief Executive of BBI Group, said “BBI is delighted to extend our lateral flow development expertise to assist Iceni in translating their HPGR™ technology to market readiness for SARS-Cov2 and Influenza testing.

With BBI’s extensive experience in the In Vitro Diagnostics arena, we are confident that the Iceni Diagnostics technology offers significant potential benefits in pathogen detection while maintaining compatibility with an established, scalable and trusted lateral flow diagnostic platform.

We look forward to working together in further addressing the global challenges presented by COVID-19.”

BBI Solutions Confirms UK Government contract for UK-Rapid Test Consortium

Successful independent evaluation from PHE for COVID-19 lateral flow antibody test

CRUMLIN-BASED BBI Solutions, a leading manufacturer of biological reagents and finished test platforms for the in-vitro diagnostics market, notes the press release issued by the UK Rapid Test Consortium (“UK-RTC”), of which BBI Solutions is a partner, on the UK Government’s first order for one million COVID-19 lateral flow antibody tests (the “AbC-19™ Rapid test”).

This first order is part of the UK Government’s plans to roll-out COVID-19 surveillance studies to help build a picture of how the virus has spread across the country.

The AbC-19™ Rapid test uses a small drop of blood from a finger-prick, and shows results in 20 minutes, without the need for a patient sample to be sent to a laboratory.

The test is currently CE-Marked for professional use, and can be administered by healthcare professionals, such as doctors, nurses, pharmacists and healthcare workers, at the point-of-care. The UK-RTC are seeking approval from the MHRA for self-test use.

The consortium will draw on BBI Solutions’ rapid test development and expertise, as well as its wider manufacturing capabilities, primarily at its headquarters at Crumlin, South Wales, and its site in Edinburgh.

BBI Solutions is also working closely with healthcare providers to optimise its smartphone diagnostic reader to be used in conjunction with the test. BBI’s patented Novarum technology will guide users at home through performing a test before securely providing the results with their healthcare provider.

The UK-RTC is reproduced in full at the end of this statement.

Dr Mario Gualano, CEO, BBI Solutions, said: “I am delighted that the UK-RTC has now received its first contract from the UK Government for our COVID-19 lateral flow antibody test.

“We believe that the AbC-19™ Rapid test has the immediate opportunity to allow the UK to build a swift and clear picture of how the virus has spread throughout the population. It also has the potential to be deployed in conjunction with vaccine candidates to help assess initial immune responses.”


Press enquiries; Alastair Milburn, Effective Communication, 857328


Press Release from the UK-RTC (issued on 6 October 2020)


UK-RTC AbC-19TM Rapid Test receives successful independent PHE evaluation


The UK Government has entered into a contract with Abingdon Health, on behalf of the UK-Rapid Test Consortium (“UK-RTC”), for the supply of the AbC-19TM Rapid Antibody tests. As part of the contract the UK Government has placed its first order for one million COVID-19 rapid antibody tests.

This follows an independent evaluation commissioned by the UK government of the AbC-19TM Rapid Antibody test, which will be published in full in due course by PHE, after peer review.   

The “AbC-19TM Rapid Test”, uses a small drop of blood from a finger-prick, and shows results in 20 minutes, without the need to go to a specialised laboratory. 

The test can be administered by healthcare professionals, such as doctors, nurses, pharmacists and healthcare workers, at the point-of-care.  It has already received the “CE mark”, which indicates health and safety conformity for goods sold in the UK and EU.     

The test will make it possible to build a swift and clear picture of how the virus has spread throughout the UK population. 

It will also be able to help establish the effectiveness of any vaccine which provides protection by creating new antibodies.  This information will be critical to managing current and future outbreaks of COVID-19.

Mass production is already under way. The antibody test will be rolled out under the government’s COVID-19 surveillance studies to help build a picture of how the virus has spread across the country. Surveillance studies are vital to develop our understanding of how antibodies work.

The UK Government helped to set up the UK Rapid Test Consortium and invested in the development of the tests.

Health Minister Lord Bethell said: “This home antibody test developed by our outstanding British scientists and researchers at the UK Rapid Test Consortium will provide critical insight into how the infection has spread, growing our understanding of coronavirus so that we can better respond to it.”

The test detects IgG antibodies to “full trimeric spike proteins” of the SARS-CoV-2 virus.  This means the test detects those antibodies which interfere with the virus’s ability to enter the human cells.

An extensive validation study performed by Ulster University involving over 1000 participant blood samples is currently under peer review for publication.

About the UK-RTC

The UK-Rapid Test Consortium was set up by Abingdon Health to bring together scientists and medical technology manufacturers to be able to deliver millions of test kits as quickly as possible.  By working together, some of the UK’s leading medical technology companies will deliver more volume more quickly to help fight Covid-19.

The UK Government supported the setup of the UK Rapid Testing Consortium and invested in the development of the rapid antibody tests.

The UK-RTC comprises Abingdon Health, the University of Oxford, Omega Diagnostics, BBI Solutions and CIGA Healthcare.

BBI creates new jobs to support next phase in COVID-19 home test development

BBI Solutions is recruiting for roles to support its work as part of a UK Government consortium, tasked with developing and manufacturing a Covid-19 Point of Care antibody test to support the government strategy on COVID-19 testing.

Four months ago, UK Government established the UK-Rapid Test Consortium (UK-RTC), in which BBI Solutions is a partner, to develop a COVID-19 lateral flow antibody test that can be used by people in their homes to determine if they have an antibody response to COVID-19, which would confirm previous infection.

This test together with the Government’s overall strategy on testing and vaccination mark a move towards detecting and eradicating the virus.

The successful completion of the development of the assay means BBI and its UK-Rapid Test Consortium (UK-RTC) partners require more staff to meet production demands in advance of final approval of the test by regulatory authorities.

BBI is investing in multiple roles at its manufacturing headquarters in Crumlin, South Wales, and these roles will be based in Manufacturing, Quality Control, Compliance, Technical Operations and Supply Chain.

Given the scale of the potential demand for the test within the UK, the Consortium will introduce a phased ramping up in capacity, but is making these key appointments in preparation for ensuring a smooth transition to high volume production at the manufacturing facilities by the end of the year.

This is a unique opportunity to join a progressive and growing organisation, which is contributing to South Wales and the UK’s resistance to the pandemic.

BBI Group Chief Executive Dr Mario Gualano said: “Given the difficult times we find ourselves in, we are delighted to announce vacancies. We have always valued our employees and they have been key to the speed at which our work with UK-RTC has progressed. We are pleased to be able to build on our team – these are exciting times for BBI and we envisage these key appointments playing their part in further developments with the Consortium.

“This is a very complex project that is being completed at extraordinary speed, compared to a normal test development programme.

“But we remain on track to deliver a test to the UK that will make a significant difference to the approach needed to manage COVID-19 infections.

“We are proud to be an integral part of this project and are thrilled with the progress to date.”

For further details on vacancies, please see

BBI Solutions Partners with Avacta Group PLC as COVID-19 Rapid Antigen Test Manufacturer


BBI Solutions is pleased to announce it has been appointed to manufacture the saliva-based rapid SARS-COV-2 antigen test that is being developed by Affimer® biotherapeutics and reagents developer Avacta Group plc (AIM: AVCT) in conjunction with Cytiva.

South Wales based BBI Solutions is a leading global developer and manufacturer of raw materials and finished test products for the in-vitro diagnostics markewith manufacturing sites in five different countries, spanning four continents.

Dr. Mario Gualano, Chief Executive of BBI Group, said: “BBI are delighted to have been appointed to lead the manufacture of Avacta’s rapid coronavirus antigen test and to be able to further extend our lateral flow expertise to addressing the global challenges presented by COVID-19.

“Our ability to respond rapidly to Avacta’s needs is testament to our team’s diagnostic expertise and the supporting manufacturing and quality systems we have implemented at our ISO13485 accredited facility.”

The manufacturing agreement between BBI and Avacta announced today comprises accelerated development and validation of a scaled-up manufacturing process that has the potential to ramp up to a production capacity of millions of tests per month. Avacta, Cytiva and BBI are in the process of technology transfer of the prototype and related manufacturing procedures for the saliva-based rapid COVID-19 antigen test from Cytiva to BBI.

Avacta aims to begin clinical validation of the test as soon as possible by using the first pilot batches generated as part of the technology transfer process for these studies. In parallel with these clinical validation studies, which will be run within the UK government’s CONDOR programme and potentially with other collaborators globally, BBI will work with Avacta and Cytiva to produce the additional technical documentation that is required for CE marking of the final product.

Dr. Alastair Smith, Chief Executive of Avacta Group commented: “I am delighted to be working with BBI to manufacture the rapid coronavirus antigen test. BBI has been excellent to work with to define a highly compressed product development timeline that will allow us to get product to market as quickly as possible.

“We anticipate very high demand for the COVID-19 rapid test and will be working with our preferred manufacturing partners at BBI to satisfy that demand. We are actively continuing our discussions with other manufacturing partners to ensure that we have access to additional manufacturing capacity to address the global need for SARS-COV-2 antigen testing in the next few years.

“As we set out in the use of proceeds at the recent fund raising, we have now expanded our product development team with the appointment of an experienced in-vitro diagnostic Product Development Manager and we are expanding the protein production facilities in order to meet the expected demand for Affimer proteins the coronavirus tests and future diagnostic tests in the pipeline.

“The diagnostics business has also been working at a rapid pace towards ISO13485 accreditation, which will streamline CE marking and other regulatory approval processes.

“I am immensely proud of what has been achieved by Avacta’s diagnostics team. It would have been challenging under normal circumstances to have made such progress in just a few months, but with the additional restrictions imposed by COVID-19, it has been an outstanding example of hard work, ingenuity and commitment from a world-class team.

“I look forward to further updating the market as we go through the next stages of manufacturing scale-up, clinical validation, regulatory approval and product launch.”

This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).

BBI Solutions welcomes consortium CE marking for professional use of its AbC-19™ Rapid Test

BBI Solutions has welcomed the UK-Rapid Test Consortium’s (UK-RTC) announcement that their COVID-19 lateral flow antibody test, designed for people to use within their own homes, has received approval to go to market for professional use.

The AbC-19TM Rapid Test has been recognised with a CE mark for professional use, after meeting the technical performance for a rapid test as stipulated by the MHRA (The Medicines and Healthcare Products Regulatory Agency.) This means that the test is now available for commercial distribution for use by professionals.

Dr Mario Gualano, Chief Executive of BBI Group, said: “We are incredibly pleased that the AbC-19™ Rapid test has achieved CE mark for professional use, following the high specificity and sensitivity attained in trial results.

“We remain on track to deliver a test to the UK population that will make a significant difference to the approach needed to manage COVID-19 infections.

“The achievement represents another key milestone for the UK-Rapid Test Consortium, and we are proud to be an integral part of this vital project.”

Three production scale batches of the product have undergone validation and verification, with the devices showing sensitivity of 98.03% (95% confidence interval 95.03% to 99.46%) to test performance and specificity of 99.56% (95% confidence interval 98.40% to 99.95%).

These figures have been calculated following analysis of a total of 450 samples taken from individuals pre-September 2019 (negatives) and 203 patients who had symptoms of COVID19, or tested positive for COVID-19, and tested positive by a commercially available Antibody ELISA test (EuroImmunTM). Results are from analyses performed at the Ulster University and Abingdon Health laboratories.

If the population is assumed to have a 10% incidence of COVID19, the AbC-19TM Rapid test shows a 99.40% accuracy and is ready for high volume manufacture by the UK-RTC.

As part of its role within the Consortium, Crumlin-based BBI Solutions’ patented smart based reader technology will guide users at home through performing a test before securely sharing the results directly with the NHS.

The process will help ensure that people who have never performed a test like this before get the right result and feel confident in understanding it, while making sure that the NHS receives all data from each test to help plan and manage the disease’s progression.

Following the CE mark accreditation, the next steps for the test include further independent evaluation and to seek performance study approval from the MHRA to facilitate the self-test usability studies to be performed with Ulster University, using around 2000 volunteers. The conclusion of this study will allow UK-RTC to seek allowance (derogation) for self-testing via the MHRA, which is expected in the coming months.

This complex project has been completed in a very short time period compared to a normal test development programme. The UK-RTC, of which BBI Solutions is a member, has been committed to delivering this vital test to the UK public, to assist in the management of COVID-19 infections and aid further understanding of the disease. The Consortium is now ready to provide this test.

For further information, contact Lydia Lambert, Effective Communication via and 07890 953402

Notes to editor:

  • Companies interested in distribution should register their interest at
  • The “UK Rapid Test Consortium” (UK-RTC) comprises Oxford University, BBI Solutions, Abingdon Health, Omega Diagnostics and CIGA Healthcare.
  • The UK-RTC is utilising BBI Solutions’ rapid test development and expertise, as well as its wider manufacturing capabilities, primarily at its headquarters at Crumlin, South Wales, and its site in Edinburgh.